BridgeMD
A trial to learn if Dato-DXd with rilvegostomig, or rilvegostomig alone, is safe and works compared with pembrolizumab in people who have advanced non-squamous non-small cell lung cancer (NSCLC) with high levels of the PD-L1 protein
EU CTIS ID: 2023-505077-32-00
What this study is testing
1. To demonstrate the superiority of the Dato-DXd in combination with rilvegostomig relative to pembrolizumab by assessment of PFS by BICR in TROP2 biomarker positive participants. 2. To demonstrate the superiority of Dato-DXd in combination with rilvegostomig relative to pembrolizumab by assessment of OS in TROP2 biomarker positive participants.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically documented non-squamous NSCLC.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and abscence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
- Must provide an available FFPE tumour sample collected ≤ 3 months prior to the start of screening. If such a sample is not available, then a FFPE tumour sample will be collected at biomarker screening (if applicable) or main screening.
- Known tumour PD-L1 expression status defined as TC ≥ 50%, determined prospectively using an FFPE tumour sample collected using the VENTANA PD-L1 (SP263) Assay).
- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline.
You likely can't join if
- Prior systemic therapy for advanced/metastatic NSCLC.
- History of leptomeningeal carcinomatosis
- Known clinically significant corneal disease
- Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
See the full eligibility criteria
- Histologically or cytologically documented non-squamous NSCLC.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and abscence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
- Must provide an available FFPE tumour sample collected ≤ 3 months prior to the start of screening. If such a sample is not available, then a FFPE tumour sample will be collected at biomarker screening (if applicable) or main screening.
- Known tumour PD-L1 expression status defined as TC ≥ 50%, determined prospectively using an FFPE tumour sample collected using the VENTANA PD-L1 (SP263) Assay).
- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline.
- ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior randomisation.
- Adequate bone marrow reserve and organ function as defined in inclusion criteria 13.
- Prior to the availability of the VENTANA TROP2 device, retrospective tumour material confirms eligibility. Once the VENTANA TROP2 device is available, prospective testing is implemented.
- Prior systemic therapy for advanced/metastatic NSCLC.
- History of leptomeningeal carcinomatosis
- Known clinically significant corneal disease
- Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- History of another primary malignancy within 3 years.
- Active or prior documented autoimmune or inflammatory disorders (with exceptions).
- Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, serious chronic gastrointestinal conditions, cardiac disease.
- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- History of any ILD/pneumonitis, including radiation pneumonitis, or drug- induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Has significant pulmonary function compromise, as determined by the investigator
- Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Japan
- India
- Vietnam
- Brazil
- Taiwan
- United States
- United Kingdom
- Australia
- Canada
- China
- Thailand
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Japan; India; Vietnam; Brazil; Taiwan and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.